BROOKE ARMY MEDICAL CENTER

🇺🇸United States
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FDA grants breakthrough status to SeaStar Medical's SCD

SeaStar Medical received FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD), targeting chronic systemic inflammation in ESRD patients on chronic hemodialysis. The SCD aims to improve survival and quality of life by modulating immune responses. The designation expedites development and review, expanding the addressable patient population to 745,000 annually. SeaStar Medical also resolved a dispute with Nuwellis, surpassed NEUTRALIZE-AKI trial enrollment halfway mark, retired long-term debt, and announced a $10 million stock sale. However, the company faces financial challenges and a shareholder class action lawsuit.
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